MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM INSERTER

Catalog Number	301-09-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.No information provided in the following section(s).
Event or Problem Description
As reported, during a initial tsa, the surgeon was inserting/impacting the humeral stem when the black plastic washer surrounding the screw fractured falling on the floor rendering the inserter useless until repaired.No pieces feel into the wound.The broken washer was retrieved and will be returned with the device.Patient was last known to be in stable condition following the event.No specific patient information is available.
Additional Manufacturer Narrative
Narrative text; section h10: (h3) the broken instrument reported was likely the result of repeat cleaning and sterilization cycles and exposure to impaction forces which likely led to crack initiation, propagation, and ultimate fracture of the stem inserter sphere.

• Brand Name: EQUINOXE
• Common Device Name: HUMERAL STEM INSERTER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11331701
• Report Number: 1038671-2021-00049
• Device Sequence Number: 19053343
• Product Code: LXH
• UDI-Device Identifier: 10885862557681
• UDI-Public: 10885862557681
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 301-09-10
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention